Device Recall Spirit Select Bed 의 리콜

Recall

74560

Class 2

Z-2332-2016

2016-06-28

2016-08-03

Terminated

United States

2017-06-08

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148254

Stryker medical is initiating a voluntary recall of the spirit select and spirit plus a-c powered hospital beds due to reports of hi-lo actuators broken at the mount ends, which could cause the bed to unexpectedly lower resulting in patient injury.

The firm, Stryker Medical, issued an "URGENT MEDICAL DEVICE RECALL" letter dated 7/8/2016 by FedEx to its customers and included a revised preventive maintenance checklist. The letter described the product, problem and actions to be taken. The customers were instructed to: locate the units listed on the attached business reply form; remove these units from service, if not possible to remove units from service, place units in the height position according to instructions; file the revised preventative maintenance checklist; return the Business Reply Form to confirm receipt of the notification by fax (269)488-8691 or email productfieldaction@stryker.com. If customers have loaned or sold any of the beds listed in this letter, please forward a copy of the recall notice to the new users and advise us of their new location in the space provided on the business reply form. Your Stryker Field service Representative will contact your facility to add support brackets to your beds. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. " Online: www.fda.gov/medwatch/report.htm " Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch , P.O. Box 3002, Rockville, MD 20847-3002 " Fax: 1-800-FDA-0178 If you have any questions or concerns, please contact Stryker Customer Service (1-800-327-0770). Our normal business hours are Monday-Friday 8 a.m-6 p.m. (EST).